Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa

Summary

Many RCT(randomized controlled trial) studies reported that tranexamic acid reduced blood loss in women who had elective cesareans. However, most of these elective cesareans are without high-risk factors of postpartum hemorrhage, such as placenta previa. The prophylactic use of tranexamic acid in the placenta previa is not clear.

studies had poor quality and lacked adequate power to assess severe adverse events.

Conditions

• Hemorrhage, Postpartum
• Placenta Previa

Interventions

DRUG

Tranexamic acid

Intravenous administration of 10 mL (1 g of tranexamic acid), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration

OTHER

0.9% sodium chloride

Intravenous administration of 10 mL placebo(0.9% sodium chloride), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration

Sponsors & Collaborators

• Dongguan Maternal and Child Health Care Hospital

  collaborator UNKNOWN

• Foshan Women's and Children's Hospital

  collaborator OTHER

• BoAi Hospital of Zhongshan

  collaborator OTHER

• Women and Children's Hospital of Chongqing Medical University

  collaborator UNKNOWN

• Tianjin Central Hospital of Gynecology Obstetrics

  collaborator OTHER

• Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan

  collaborator UNKNOWN

• Urumqi Maternal and Child Health Care Hospital

  collaborator UNKNOWN

• Zhuhai Women and Children's Hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Hunan Provincial Maternal and Child Health Care Hospital

  collaborator OTHER

• Dalian women and children's medical group

  collaborator UNKNOWN

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Huadu District People's Hospital of Guangzhou

  collaborator OTHER

• Northwest Women's and Children's Hospital, Xi'an, Shaanxi

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Shenzhen Maternity & Child Healthcare Hospital

  collaborator OTHER

• Shenzhen Baoan Women's and Children's Hospital

  collaborator UNKNOWN

• Dongguan People's Hospital

  collaborator OTHER_GOV

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Peking Union Medical College

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Fifth Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Shijiazhuang Obstetrics and Gynecology Hospital

  collaborator OTHER

• Guangzhou Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-12

Primary Completion

2025-02-11

Completion

2025-03-23

Countries

• China

Study Locations